Cardiac Surgery, Disorder, Heart, Postoperative
Conditions
Keywords
Cardiac Surgery, Transfusion
Brief summary
TRICS-IV is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in moderate to high risk patients who are 65 years of age or younger undergoing cardiac surgery on cardiopulmonary bypass, using a superiority trial design.
Interventions
Patients will receive a RBC transfusion if their Hb concentration is \<75 g/L (\<7.5 g/dL; \<4.7mmol/L) intraoperatively and/or postoperatively.
Patients will receive a RBC transfusion if their Hb concentration is \<95 g/L (\<9.5 g/dL; \<5.9mmol/L) intraoperatively, or postoperatively in the ICU; and/or \<85 g/L (\< 8.5 g/dL; \<5.3mmol/L) on the ward.
Sponsors
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. ≥18 and ≤65 years of age 2. Planned cardiac surgery using cardiopulmonary bypass 3. Informed consent obtained 4. Preoperative European System for Cardiac Operative Risk Evaluation (EuroSCORE I) of 6 or more
Exclusion criteria
1. Patients who refuse participation 2. Patients who are unable to receive or who refuse blood products 3. Patients who are involved in a preoperative autologous pre-donation program 4. Patients who are having a heart transplant or having surgery solely for an insertion of a ventricular assist device 5. Pregnancy or lactation (a negative pregnancy test must be obtained prior to randomization for women of childbearing potential)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite score of any one of the following events occurring 6 months after cardiac surgery: (1) all-cause mortality; (2) myocardial infarction; (3) new onset renal failure requiring dialysis; or (4) new focal neurological deficit (stroke). | Within 6 months after cardiac surgery. | Any of all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, or new focal neurological deficit (stroke). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite and individual all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke). | Up to hospital discharge or after 28 days postoperatively, whichever comes first. | Composite and individual incidence of all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke). |
| Length of stay in the ICU and hospital. | Up to hospital discharge or after 28 days postoperatively, whichever comes first. | Length of stay in the ICU and hospital in days. |
| Prolonged low output state. | Up to hospital discharge or after 28 days postoperatively, whichever comes first. | Defined as the need for two or more inotropes for 24 hours or more, intra-aortic balloon pump or ventricular assist device postoperatively. |
| Duration of mechanical ventilation. | Up to hospital discharge or after 28 days postoperatively, whichever comes first. | Time on mechanical ventilation. |
| Incidence of infection. | Up to hospital discharge or after 28 days postoperatively, whichever comes first. | Defined as septic shock with positive blood cultures; pneumonia defined as autopsy diagnosis or roentgenographic infiltrate and at least two out of three of the following criteria: fever, leukocytosis, and positive sputum culture; and/or deep sternal or leg wound infection requiring intravenous antibiotics and/or surgical debridement. |
| Acute kidney injury. | Up to hospital discharge or after 28 days postoperatively, whichever comes first. | Defined by the Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guideline - a 50% increase in serum creatinine within 1 week or a 26.5 mmol/L increase within 48 hours. |
| Incidence of each individual component of the primary outcome: all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke). | Within 6 months after cardiac surgery. | Incidence of all-cause mortality, myocardial infarction, new onset renal failure requiring dialysis, and new focal neurological deficit (stroke). |
| Incidence of gut infarction. | Up to hospital discharge or after 28 days postoperatively, whichever comes first. | Confirmed by imaging (e.g. angiography), autopsy, or through surgical means. |
| Hospital visits. | Within 6 months after cardiac surgery. | Hospitalization and/or emergency visits and coronary revascularization after index procedure. |
| Transfusion requirements. | Up to hospital discharge or after 28 days postoperatively, whichever comes first. | The proportion of patients transfused and the number of blood products utilized (RBCs, plasma, platelets). |
| Incidence of seizures. | Up to hospital discharge or after 28 days postoperatively, whichever comes first. | Generalized or focal tonic-clonic movements consistent with seizure; or electroencephalogram demonstrating epileptiform discharges; or diagnosis of seizures by neurologist or neurosurgeon consultation. |
| Incidence of encephalopathy. | Up to hospital discharge or after 28 days postoperatively, whichever comes first. | Unexpected delayed awakening or severely altered mental status (unconscious despite no sedative medication for more than 5 days), or encephalopathy documented by neurologist or neurosurgeon or psychiatrist consultation. |
| Delirium. | Up to hospital discharge or after 28 days postoperatively, whichever comes first. | Confusion Assessment Method (CAM) or CAM-ICU (even on 1 occasion), or Intensive Care Delirium Screening Checklist (ICDSC) \> 3, or 3D-CAM, or 4AT ≥4, or more than one dose of haloperidol or similar antipsychotic drug, or documented delirium by neurologist or neurosurgeon or psychiatrist consultation. |
Countries
Australia, Canada, Colombia, Egypt, Greece, India, Namibia, Nepal, Romania, Russia, Singapore, South Africa, Spain, Switzerland, United Kingdom, United States
Contacts
Primary ContactDavid Mazer, MD
Outcome results
None listed